Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of the following election of species entities:
PNG
media_image1.png
56
500
media_image1.png
Greyscale
in the reply filed on 5/4/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
An action on the merits of claims 1-19 is contained herein.
Priority
This application claims priority to United States provisional application no.
63/216,909, filed June 30, 2021.
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
In claim 2, certain embodiments are simply referred to as “YM-348, MK-212, etc.” wherein the chemical identities of these species are not defined within said claim. The skilled artisan would need to refer to the disclosure and/or drawings to ascertain the structures of these compounds which does not comply with 35 U.S.C. 112 2nd. See Ex parte Fressola, 27 USPQ2d 1608:
“The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims in utility applications that define the invention entirely by reference to the specification and/or drawings, so-called “omnibus” or “formal” claims, while perhaps once accepted in American patent practice, are properly rejected under Section 112 Para. 2 as failing to particularly point out and distinctly claim the invention. See MPEP Section 706.03(h) (5th ed., rev. 14, Nov. 1992); Landis, Mechanics of Patent Claim Drafting, Section 2 (1974). This analysis is limited to claims in utility applications. Plant patent claims are defined “in formal terms to the plant shown and described.” Claims in design patents are recited in formal terms to the ornamental design “as shown” or, where there is a properly included special description of the design, the ornamental design “as shown and described.” MPEP Section 1503.01…….The general rule is that the claims should be self-contained; that is, they should not expressly rely upon the description or drawing to give them meaning. . . . The terms “substantially as described” and the like, once much used in claims (GLASCOCK 1943 Section 5640) are now rarely seen. The Office disregards them in interpreting claims. . . . Claims consisting only in a reference to the disclosure, as “The features of novelty herein disclosed,” are not allowed except in design cases.…..A claim which refers to the specification defeats the purpose of a claim.”
The examiner recommends that the chemical structures or names which are associated with these abbreviations are inserted into the claim to obviate the rejection.
Claim Rejections – Improper Markush Grouping Rejection
Claims 1-12, 14-17, and 19 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
In re Harnish, 206 USPQ 300, 305, says, “ …we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification (see claim 1 below for pictorial example):
PNG
media_image2.png
605
882
media_image2.png
Greyscale
.
Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371.
Indeed, as was stated in Ex parte Haas, 188 USPQ 374, “The rejection of a claim as containing an improper Markush grouping has a relatively long history in Office practice. The Court of Customs and Patent Appeals, at least as far back as 1942, has recognized that a rejection may be based upon the Examiner's holding that the claim has an improper Markush group. See In re Swenson, 30 CCPA 764, 132 F.2d 336, 56 USPQ 180 , citing Ex parte Palmer, 398 OG 707, 1930 CD 3.”
It should be noted that in Harnish, there was a substantial structural feature from which the common use flowed and that the claimed compounds all belong to a subgenus. That is exactly what is lacking in this case, as there is no substantial structural feature when viewing the compound as a whole. The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
For example the claimed 5-HT2C agonists comprise of various molecules with different scaffolds and structure where clearly classifying these compounds as one subgeneric group would be repugnant to scientific classification. Thus, the first requirement is not met as described above. Secondly, there is little evidence provided that the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature as explained previously.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
The examiner recommends that the claims should be amended to include only species that share a single structural similarity and a common use to overcome the rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 12, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over OGASA, T., et al., Systemic Administration of Serotonin 2A/2C Agonist Improves Upper Airway Stability in Zucker Rats, American Journal of Respiratory and Critical Care Medicine, Vol. 170, No. 7 pages 804-810, October 1, 2004-mentioned in IDS.
OGASA, T., et al. teach that administration (appears to be immediate release) of a serotonin 2A/2C agonist to obese Zucker rats improves upper airway stability (see abstract and page 804, bottom left column). In this case the obese rats initially exhibited before administration reduced ventilatory responses to hypercapnia and hypoxia which is characteristic of obesity hypoventilation syndrome as stated in the instant specification at [0003]. Thus the claims are anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-9, 12, 14, 15, and 19 are rejected under AIA 35 U.S.C. 103(a) as being obvious over OGASA, T., et al., Systemic Administration of Serotonin 2A/2C Agonist Improves Upper Airway Stability in Zucker Rats, American Journal of Respiratory and Critical Care Medicine, Vol. 170, No. 7 pages 804-810, October 1, 2004-mentioned in IDS.
OGASA, T., et al. taught what was described above. The document does not explicitly teach the dosage amounts or other modes of administration or formulation characteristics described in the instant claims. However the aforementioned would fall under routine optimization by one skilled in the art.
Generally, such differences will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such changes is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12, 14-17, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The skilled artisan would not have adequate reason to believe that Applicant had possession of the claimed “prodrugs” or the genus of 5-HT2C agonists claimed in the recited method. No where does the specification allude to the specific identities of these prodrugs or which functional groups a prodrug may possibly comprise of. There are no working examples of these unknown prodrugs in the disclosure. It is unknown whether these prodrugs may actually afford a compound which is readily hydrolyzed in vivo to provide a compound with therapeutic activity. In reference to the recited 5-HT2C agonists, there appears to be only one working example consisting of monotherapy with lorcaserin. Once again, there are no working embodiments consisting of other agonists intended to be embraced by the claim scope. Thus, how would one skilled in the art expect that Applicant was indeed in possession of the claimed prodrugs and full scope of agonists recited within the claims? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
PNG
media_image3.png
18
19
media_image3.png
Greyscale
The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples and nature of the described genus, Applicants are not in possession of the claimed prodrugs or the recited genus of 5-HT2C agonists.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating obesity hypoventilation syndrome using the 5-HT2C agonist lorcaserin alone, does not reasonably provide enablement for the full scope of conditions and agonists embraced by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Some experimentation is not fatal; the issue is whether the amount of experimentation is "undue"; see In re Vaeck, 20 USPQ2d 1438, 1444. Analysis is described below:
(A) Breadth of claims: The claims embrace a myriad of 5-HT2C agonists that vary independently and lead to compounds of a wide variety of structures. These compounds encompass molecules that widely vary in the physical and chemical properties such as size, molecular weight, acidity, basicity, and properties that are known in the art to greatly influence pharmacokinetic and pharmacodynamic parameters, not to mention the ability to productively bind to claimed biological target molecules. The claims cover compounds easily in the millions given the number of possible rings, thus the claims are very broad. A similar analysis is applicable to the myriad of conditions potentially embraced by the claims where said conditions associated with central hypoventilation include those known and also unknown in the art.
(B) The nature of the invention:
(C) State of the Prior Art:
(D) Skill of those in the art: The level of skill in the art is high.
(E) Level of predictability in the art: It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved," and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(F) Direction or Guidance: Little guidance or direction is provided by Applicant in reference to using other 5-HT2C agonists and the treatment of other conditions embraced by the claim language besides that stated herein. Specification offers no teachings or suggestion as to how to make and use these compounds in the full scope of the manner as claimed. Also, note MPEP 2164.08(b) which states that claims that read on "... significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative.";
(G) Working Examples: The specification provides working examples consisting of in vivo test results using lorcaserin on patients having sleep apnea and subsequent ventilation effects (note that no further information is provided regarding other pertinent characteristics about these patients so the examiner assumes that they are obese and meet the criteria for obesity hypoventilation syndrome unless further information is supplied by Applicant stating the contrary).
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p).
(H) The quantity of experimentation needed: Since there are very limited working examples as described above, the amount of experimentation is expected to be high and burdensome. Applicant fails to provide guidance and supporting information for how to make and/or use the thousands of other compounds which are encompassed by the claims, therefore undue experimentation would be expected.
Due to the level of unpredictability in the art, the very limited guidance provided, and the lack of working examples, the applicant has shown lack of enablement. MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." That conclusion is clearly justified here.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
Prosecution Insights